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Investing.com -- BeOne Medicines AG DRC (NASDAQ:ONC) stock rose 4.4% following the announcement of positive topline results from a Phase 1/2 study of sonrotoclax in patients with relapsed/refractory mantle cell lymphoma (MCL).
The company reported that the study met its primary endpoint of overall response rate as assessed by an independent review committee. The trial evaluated sonrotoclax, described as a next-generation and potentially best-in-class investigational BCL2 inhibitor, in 125 adult patients who had previously been treated with a Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy.
According to BeOne, the treatment demonstrated "clinically meaningful responses" in this heavily pretreated population. The company also noted promising results across secondary efficacy endpoints, including complete response rate, duration of response, and progression-free survival. The safety profile was reported as "generally well-tolerated" with "manageable" toxicities.
"These topline results for sonrotoclax underscore its potential to deliver meaningful and durable responses and offer the first BCL2 inhibitor for patients with R/R MCL, if approved," said Lai Wang, PhD, Global Head of R&D at BeOne Medicines.
The company plans to submit the data to the U.S. Food and Drug Administration and other global regulatory bodies for potential approval. Applications for sonrotoclax are already under review by China’s National Medical Products Administration for potential accelerated approval in R/R MCL and R/R CLL/SLL.
The Phase 3 confirmatory CELESTIAL-RR MCL study is currently underway, with the first patient enrolled earlier this year. The FDA has previously granted sonrotoclax Orphan Drug Designation for treating patients with MCL.
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